Evidence map›Paper›PMID 36998225›Full record

ArticleJournal of gynecologic oncology2023

Efficacy of lymph node dissection on stage IIICr of cervical cancer before CCRT: study protocol for a phase III, randomized controlled clinical trial (CQGOG0103).

Misi He, Mingfang Guo, Qi Zhou, Ying Tang, Lin Zhong, Qing Liu, Xiaomei Fan, Xiwa Zhao, Xiang Zhang, Gang Chen and 5 more

Registry-linked trialOpen access · diamondAbstract readClinical Trial Protocol
In one paragraph

Article in Journal of gynecologic oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04555226 (Randomized Controlled Trial of the Efficacy of Lymph Node Dissection on Stage IIICr of Cervical Cancer), which is not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
3.0field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04555226 narecruitingnot on this map

Randomized Controlled Trial of the Efficacy of Lymph Node Dissection on Stage IIICr of Cervical Cancer

TypeinterventionalSponsorChongqing University Cancer HospitalRan2021 to 2032Enrolled452ConditionsCervical CancerArmsLymph node dissection, Standard chemoradiation±pembrolizumab, Chemoradiation± pembrolizumab
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 10 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 9 institutions in 1 country.

Misi He *Department of Gynecology Oncology, Chongqing University Cancer Hospital, Chongqing, China.ORCID 0000-0001-8469-7690
Mingfang Guo *Department of Gynecology Oncology, Chongqing University Cancer Hospital, Chongqing, China.ORCID 0000-0002-2024-2141
Qi ZhouDepartment of Gynecology Oncology, Chongqing University Cancer Hospital, Chongqing, China.ORCID 0000-0001-5673-4263
Ying TangDepartment of Gynecology Oncology, Chongqing University Cancer Hospital, Chongqing, China.ORCID 0000-0003-0428-1228
Lin ZhongDepartment of Gynecology Oncology, Chongqing University Cancer Hospital, Chongqing, China.ORCID 0000-0002-9224-9537
Qing LiuGansu Provincial Maternity and Child-Care Hospital/Gansu Provincial Central Hospital, Lanzhou, China.ORCID 0000-0002-2568-4029
Xiaomei FanFourth Hospital of Hebei Medical University, Hebei, China.ORCID 0000-0003-3035-876X
Xiwa ZhaoFourth Hospital of Hebei Medical University, Hebei, China.ORCID 0000-0003-4451-8808
Xiang ZhangDepartment of Gynecologic Radiation Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China.ORCID 0000-0002-6706-3925
Gang ChenDepartment of Gynecological Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.ORCID 0000-0002-8320-6594
Yuanming ShenDepartment of Gynecologic Oncology, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China.ORCID 0000-0002-0474-3472
Qin XuDepartment of Gynecology, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, China.ORCID 0000-0002-3689-0266
Xiaojun ChenDepartment of Gynecology, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.ORCID 0000-0002-5493-1500
Yuancheng LiCancer Hospital of Shantou University Medicine College, Shantou, China.ORCID 0000-0001-5243-0713
Dongling ZouDepartment of Gynecology Oncology, Chongqing University Cancer Hospital, Chongqing, China. cqzl_zdl@163.com.ORCID 0000-0001-9158-8783
Chongqing University · CNHebei Medical University · CNFujian Medical University · CNGansu Provincial Maternal and Child Health Hospital · CNObstetrics and Gynecology Hospital of Fudan University · CNShantou University · CNTongji Hospital · CNWomen's Hospital, School of Medicine, Zhejiang University · CNZhejiang Cancer Hospital · CN

Funding

Chongqing Municipal Public Health Bureau, Chongqing People's Municipal Government 2021jstg001Chongqing Science and Health Committee joint medical research project 2021MSXM295Chongqing Science and Technology Commission cstc2020jxjl130019National Natural Science Foundation of China 82073129Shapingba Science and Technology Committee of Chongqing Jcd202116
6 · The paper itself

Abstract

backgroundCervical cancer is still present a major public health problem, especially in developing countries. In International Federation of Gynaecology and Obstetrics 2018, allowing assessment of retroperitoneal lymph nodes by imaging and/or pathological findings and, if deemed metastatic, the case is designated as stage IIIC (with r and p notations). Patients with lymph node metastases have lower overall survival (OS), progression free survival (PFS), and survival after recurrence, especially those who have unresectable macroscopical positive lymph nodes. Retrospective analysis suggests that there may be a benefit to debulking macroscopic nodes that would be otherwise difficult to sterilize with standard doses of radiation therapy. However, there are no prospective study reporting that resecting macroscopic nodes before concurrent chemoradiation therapy (CCRT) would improve PFS or OS of cervical cancer and no guidelines for surgical resection of bulky lymph nodes. The CQGOG0103 study is a prospective, multicenter and randomized controlled trial (RCT) evaluating lymph node dissection on stage IIICr of cervical cancer.

methodsEligible patients are histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, adeno-squamous cell carcinoma. Stage IIICr (confirmed by computed tomography [CT]/magnetic resonance imaging/positron emission tomography/CT) and the short diameter of image-positive lymph node ≥15 mm. 452 patients will be equally randomized to receive either CCRT (pelvic external-beam radiotherapy [EBRT]/extended-field EBRT + cisplatin [40 mg/m²] or carboplatin [the area under curve=2] every week for 5 cycles + brachytherapy) or open/minimally invasive pelvic and para-aortic lymph node dissection followed by CCRT. Randomization is stratified by status of para-aortic lymph node. The primary endpoint is PFS. Secondary endpoints are OS and surgical complications. A total of 452 patients will be enrolled from multiple hospitals in China within 4 years and followed up for 5 years.

trial registrationClinicalTrials.gov Identifier: NCT04555226.

Indexed as

AdenocarcinomaUterine Cervical NeoplasmsChemoradiotherapyClinical Trials, Phase III as TopicFemaleHumansLymph Node ExcisionLymph NodesMulticenter Studies as TopicNeoplasm StagingRandomized Controlled Trials as TopicRetrospective StudiesCervical CancerLymph Node DissectionRCTStage IIICr

Identifiers

PMID36998225
PMCPMC10157346
OpenAlexW4360914066

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.